The Naval Medical Center San Diego (NMCSD) intends to award a sole source purchase order under the authority of FAR 13.106-1(b), due to only one source being available to meet the Government's needs, to the Medtronic, Inc., 710 Medtronic Pkwy, Minneapolis, MN.
The requirement is for a CoreValve Transcatheter Aortic Valve, Delivery System, and Compression Loading System.
CoreValve Transcatheter Aortic Valve used in treating patients with an aortic annulus diameter from 18-29 mm, consists of a porcine pericardial valve constructed on a nitinol, self- expanding frame. The bioprosthesis is designed to replace the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve. It is implanted in a percutaneous, beating-heart procedure on an 18F delivery catheter.
Delivery system: The 18F catheter is used with the 26, 29, and 31 mm valves to deliver the valve to the native annulus using a femoral, subclavian/axillary, or direct aortic approach. It is compatible with a 0.035 in guidewire.
Compression Loading System: The CLS compresses the bioprosthesis into the catheter and consists of 5 component-outflow cone, outflow cap, inflow cone, outflow tube, and inflow tube.
This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.
Capability statements are due by 4:00 PM Local Time, July 27, 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: [email protected]